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Device to Cut Seizures Gets F.D.A.'s Nod

The Food and Drug Administration today approved the first medical device intended to reduce epileptic seizures.

The device, the Neuorcybernetic Prosthesis System, made by Cyberonics Inc. of Webster, Tex., was approved for use in conjunction with drugs or surgery in adults and adolescents with what are called partial onset seizures, the agency said.

The approval came only 19 days after an F.D.A. advisory committee recommended it. The agency said it received an application on Jan. 27 to market the device and expedited its review because of the product's potential for reducing seizures in people who lack effective, alternative treatment.

The device consists of a generator implanted under the collarbone like a pacemaker and connected to the vagus nerve in the neck, where it delivers electrical signals to the brain to control seizures. It includes an external programming system used by a doctor to change stimulation settings. Patients can turn the stimulator on and off with a magnet.

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In clinical trials the device was implanted in 454 patients with poorly controlled seizures at 45 medical centers in the United States, Canada and Europe. The agency said that most of the patients, who also continued to take anti-seizure medicine, showed some improvement.

In one study, half the patients who used the device had at least 20 percent fewer seizures per day. For about a quarter of the patients, the decrease was more than 50 percent. But seizures actually increased for about one-fifth of the patients.

Nine patients died during the studies, the agency said, but none of the deaths were believed to have been caused by the device. Patients reported several side effects, including coughing, hoarseness, voice changes and shortness of breath.

The agency said it had asked the company to evaluate its data to find out whether it could predict which patients were most likely to benefit from the device.